Effects of Dietary Fiber on Insulin Sensitivity

January 26, 2012 updated by: Ingredion Incorporated

Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women

This study will examine the effects of a dietary fiber on insulin sensitivity in overweight and obese women. The fiber will be added to snack foods and women will consume the foods for four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in another period. In a third period, no fiber will be added to the snack foods. Insulin senstivity will be measured at the end of each treatment period.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Clinical Research Unit
        • Principal Investigator:
          • Barbara Gower, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Impaired fasting glucose
  • Overweight and obese

Exclusion Criteria:

  • Diabetes, Presence of chronic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose
15 g of fiber per day will be added to snack foods
Dietary supplement: Dietary Fiber
Dietary fiber will be added to snack foods
Experimental: High dose
30 g of fiber per day will be added to snack foods
Dietary supplement: Dietary Fiber
Dietary fiber will be added to snack foods
Placebo Comparator: No fiber
Snack foods without fiber will be given
Dietary supplement: Dietary Fiber
Dietary fiber will be added to snack foods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: 5-hr test, performed 3 times within a 20-week period
A frequently sampled intravenous blood glucose tolerance test will be performed.
5-hr test, performed 3 times within a 20-week period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitocondrial function
Time Frame: 3 times, with a 20-week period
A muscle biospy will be taken to assess mitochondrial function
3 times, with a 20-week period
Meal tolerance test
Time Frame: 3 times, within a 20-week period
A high-fat meal will be given and blood will be drawn over a three-hr period
3 times, within a 20-week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ingredion Incorporated

Investigators

  • Principal Investigator: Barbara Gower, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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